| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00855574005346 | FBPUS | Personal Use Kit OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 2 | 00855574005339 | FBT-StarterS | Starter Pack OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 3 | 00855574005322 | FOB50S | Test Kit OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 4 | 00855574005315 | FOBBTLS | Sampling Bottles OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 5 | 00855574005308 | FOBSTRS | OC-Light S Test Strips | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 6 | 00855574005292 | 662160 | BTA TRAK - Internationally Labeled | MMW | System, Test, Tumor Marker, Monitoring, Bladder | 2 | BTA TRAK | |
| 7 | 00855574005285 | 662150 | BTA TRAK - USA Labeled | MMW | System, Test, Tumor Marker, Monitoring, Bladder | 2 | BTA TRAK | |
| 8 | 00855574005193 | FBPU-BULKS | Personal Use Kit Bulk, OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 9 | 00816917025728 | FBPUS-UH | Personal Use Kit OC-Light S, for Union Hospital | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 10 | 00816917025704 | FBPUS-MBAP | Personal Use Kit OC-Light S, for Missouri Baptist Med Ctr | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 11 | 00816917025681 | FBPUS-EHICH | Personal Use Kit OC-Light S, for Emanate Health Inter-Comm Hospital | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 12 | 00816917025582 | FBPUS-GOSH | Personal Use Kit OC-Light S, for Goshen Health | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 13 | 00816917025506 | FBPUS-MONH | Personal Use Kit OC-Light S, for Monument Health | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 14 | 00816917025223 | FBPUS-LHCH | Personal Use Kit OC-Light S, for Lebauer Healthcare Cone Health | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 15 | 00816917025087 | FBPUS-AL | Personal Use Kit OC-Light S, for Alverno Labs | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 16 | 00816917025063 | FBPUS-VFC | Personal Use Kit OC-Light S, for Venice Family Clinic | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 17 | 00816917025056 | FBPUS-OMC | Personal Use Kit OC-Light S, for Olympic Medical Center | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 18 | 00816917025001 | FBPUS-LCPSC | Personal Use Kit OC-Light S, Custom Kit for Lexington Clinic, PSC | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 19 | 00816917024820 | FBPUS-AAPH | Personal Use Kit OC-Light S, Custom Kit for Albany Area Primary Healthcare, Inc. | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 20 | 00816917024813 | FBPUS-SCHS | Personal Use Kit OC-Light S, Custom Kit for St. Charles Health System | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 21 | 00816917024806 | FBPUS-GRPH | Personal Use Kit OC-Light S, Custom Kit for Guthrie Robert Packer Hospital | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 22 | 00816917024790 | FBPUS-CHA CPCC | Personal Use Kit OC-Light S, Custom Kit for (CHA) Cambridge Primary Care Center | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 23 | 00816917024783 | FBPUS-CMH MRHC | Personal Use Kit OC-Light S, Custom Kit for Comm Mem Hosp/Moorland Reserve Healt Personal Use Kit OC-Light S, Custom Kit for Comm Mem Hosp/Moorland Reserve Health Center (Froedert) | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 24 | 00816917024592 | FBPUS-BMHL | Personal Use Kit OC-Light S, Custom Kit for Bronson Methodist Hospital Laboratory | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 25 | 00816917024578 | FBPUS-MWH | Personal Use Kit OC-Light S, Custom Kit for Melrose Wakefield Hosp | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 26 | 00816917024561 | FBPUS-CHWC | Personal Use Kit OC-Light S, Custom Kit for Community Hospitals & Wellness Cente Personal Use Kit OC-Light S, Custom Kit for Community Hospitals & Wellness Centers - Cardinal | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 27 | 00816917024554 | FBPUS-CMH FHMG | Personal Use Kit OC-Light S, Custom Kit for Froedtert Health Medical Group | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 28 | 00816917024509 | FBPUS-ADL | Personal Use Kit OC-Light S for ADL | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 29 | 00816917024493 | FBPUS-ARMC | Personal Use Kit OC-Light S for ARMC | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 30 | 00816917024431 | FBPUS-VA1 | OC-Light S Personal Use Kit for VA1 | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 31 | 00816917023861 | FBPUS-ABRMP-ESK | Personal Use Kit OC-Light S, Custom Kit for Eskenazi | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 32 | 00816917023854 | FBPUS-UFCH | Personal Use Kit OC-Light S, Custom Kit for Shands Jksn | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 33 | 00816917023847 | FBPUS-LCHC | Personal Use Kit OC-Light S, Custom Kit for Lawndale CHC | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 34 | 00816917023830 | FBPUS-FMA | Personal Use Kit OC-Light S, Custom Kit for Flgler Med Ass | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 35 | 00816917023823 | FBPUS-CHA MFMC | Personal Use Kit OC-Light S, Custom Kit for Mldn Fam MC | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 36 | 00816917023816 | FBPUS-CHA FHMG | Personal Use Kit OC-Light S, Custom Kit for Froedtert Health Medical Group | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 37 | 00816917023809 | FBPUS-CHA ECCC | Personal Use Kit OC-Light S, Custom Kit for Cambridge Care Center | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 38 | 00816917023793 | FBPUS-EC | Personal Use Kit OC-Light S, Custom Kit for Elkhart Clinic | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 39 | 00816917023786 | FBPU-CUSTOMS | Personal Use Kit OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 40 | 00816917023779 | FBPUS-CA | Personal Use Kit OC-Light S, Clinical Associates | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 41 | 00816917023762 | FBPU-ADRS | Personal Use Kit OC-Light S, Addressed | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 42 | 00816917023755 | FBPUS-AFPC | Personal Use Kit OC-Light S, Amarillo Family | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 43 | 00816917023748 | FBPU-NBRMP-120S | 6 Personal Use Kits OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 44 | 00816917023731 | FBPU-ABRMP-120S | 6 Personal Use Kits OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 45 | 00816917023724 | FBPU-120S | 6 Personal Use Kits OC-Light S | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 46 | 00816917023649 | FBPUS-MCY | Personal Use Kit OC-Light S for St. Joseph Mrcy Oklnd | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 47 | 00816917023632 | FBPU-NBRMPS | Personal Use Kit OC-Light S, Custom Kit for NBRMPS | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 48 | 00816917023625 | FBPU-ABRMPS | Personal Use Kit OC-Light S, Custom Kit for ABRMPS | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 49 | 00816917023618 | FBPU-CUSTOM-120S | Personal Use Kit OC-Light S, Custom Kit x 6 | KHE | Reagent, Occult Blood | 2 | OC-Light S | |
| 50 | 00816917022963 | FBPUS-WAFH | Personal Use Kit OC-Light S, Custom Kit for W.A. Foote Hospital | KHE | Reagent, Occult Blood | 2 | OC-Light S |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00893230002032 | KT-313 | KT-313 | Fecal Occult Blood Test | EDI™ CARE™ | EPITOPE DIAGNOSTICS INC |
| 2 | 00860146001527 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
| 3 | 00860146001510 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
| 4 | 00860146001503 | MDiFOB25 | Fecal Occult Blood (FOB) Rapid Test Device (Feces) | MD DrugScreen | MEDICAL DISPOSABLES CORP | |
| 5 | 00857338006934 | T1-CK50MUS | T1-CK50MUS | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit with Mailers (Made in USA) | HEMOSURE® | HEMOSURE INC. |
| 6 | 00857338006323 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE® | HEMOSURE INC. |
| 7 | 00857338006316 | T1-CM50 | T1-CM50 | Hemosure iFOB 50 Mailers Only Box Set | HEMOSURE® | HEMOSURE INC. |
| 8 | 00857338006309 | T1-CK30 | T1-CK30 | Hemosure iFOB Test 30 Cassettes and 50 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
| 9 | 00857338006194 | T1-TB10 | T1-TB10 | Hemosure iFOB Buffer Tube Box Set (10 Purple Cap Tubes with Short Labels) | HEMOSURE® | HEMOSURE INC. |
| 10 | 00857338006132 | T1-CM50 | T1-CM50 | Hemosure FOB 50 Mailers Only Box Set | HEMOSURE | HEMOSURE INC. |
| 11 | 00857338006125 | DUO-CM10 | DUO-CM10 | Hemosure iFOB Prepacked 10 Mailers Box Set with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
| 12 | 00857338006118 | T1-TB50 | T1-TB50 | Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels) | HEMOSURE | HEMOSURE INC. |
| 13 | 00857338006101 | Prepack-CM25 | Prepack-CM25 | Individual Prepacked Mailer with One Tube in Each Mailer; Packed in a Plastic Bag | HEMOSURE® | HEMOSURE INC. |
| 14 | 00857338006095 | DUO-iFOB20 | DUO-iFOB20 | Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with T Hemosure iFOB Prepacked DUO-iFOB Test 20 Cassettes and 10 Mailers Box Kit with Two Buffer Tubes in Each Mailer | HEMOSURE® | HEMOSURE INC. |
| 15 | 00857338006088 | T1-CK30T | T1-CK30T | Hemosure iFOB Test 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
| 16 | 00857338006071 | T1-CT30 | T1-CT30 | Hemosure iFOB Test 30 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
| 17 | 00857338006064 | T1-CT50 | T1-CT50 | Hemosure FOB Test 50 Cassettes Box Set | HEMOSURE® | HEMOSURE INC. |
| 18 | 00857338006057 | T1-CK50 | T1-CK50 | Hemosure iFOB Test 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
| 19 | 00857338006040 | PRE-PACK iFOB20 | PRE-PACK iFOB20 | Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One B Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One Buffer Tube in Each Mailer | HEMOSURE® | HEMOSURE INC. |
| 20 | 00857338006033 | T1-CK25 | T1-CK25 | Hemosure iFOB Test 25 Cassettes and 25 Collection Tubes per Box Kit without Mailer | HEMOSURE® | HEMOSURE INC. |
| 21 | 00857338006026 | T1-CK10 | T1-CK10 | Hemosure iFOB Test 10 Cassettes and 10 Collection Tubes per Box Kit with Mailers | HEMOSURE® | HEMOSURE INC. |
| 22 | 00857338006019 | T1-CK30 | T1-CK30 | contains T1-CT30, T1-TB50, T1-CM50. T1-CT30: Hemosure iFOB Test 30 Cassettes Box contains T1-CT30, T1-TB50, T1-CM50. T1-CT30: Hemosure iFOB Test 30 Cassettes Box SetT1-TB50: Hemosure iFOB Buffer Tube Box Set (50 Purple Cap Tubes with Long Labels)T1-CM50: Hemosure iFOB 50 Mailers Only Box Set | Hemosure | HEMOSURE INC. |
| 23 | 00855574005346 | FBPUS | Personal Use Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 24 | 00855574005339 | FBT-StarterS | Starter Pack OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 25 | 00855574005322 | FOB50S | Test Kit OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 26 | 00855574005315 | FOBBTLS | Sampling Bottles OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 27 | 00855574005308 | FOBSTRS | OC-Light S Test Strips | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 28 | 00855574005193 | FBPU-BULKS | Personal Use Kit Bulk, OC-Light S | OC-Light S | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 29 | 00855574005094 | FOBSTR | OC-Light Test Strips | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 30 | 00855574005070 | FOBBTL | Sampling Bottles OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 31 | 00855574005063 | FOB50 | OC-Light Test Kit | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 32 | 00855574005056 | FBT-Starter | Starter Pack OC-Light | OC-Light | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC | |
| 33 | 00853691007595 | 1 | FOB Rapid Test Cassette | FOB Rapid Test Cassette | ACRO BIOTECH INC | |
| 34 | 00850093003354 | 01 | 90035.01 | InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
| 35 | 00850093003323 | 01 | InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bulk pouch of 200 Strips (Part Number 12041.01) | InSure® ONE™ | ENTERIX INC. | |
| 36 | 00850093003316 | 01 | InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027 InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01) | InSure® ONE™ | ENTERIX INC. | |
| 37 | 00850093003309 | 01 | 90002.01 | InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 individually InSure® ONE™ Sample Kit - NOT FOR SALEContains 2 Collection Kits, 2 individually-pouched Test Strips, and 1 bottle of Run Buffer (9mL) | InSure® ONE™ | ENTERIX INC. |
| 38 | 00850093003293 | 01 | 14103.01 | InSure® ONE™ Run Buffer - 1 Liter Bottle | InSure® ONE™ | ENTERIX INC. |
| 39 | 00850093003286 | 01 | 11018.01 | InSure® ONE™ Test Cards for QC - 50 pack | InSure® ONE™ | ENTERIX INC. |
| 40 | 00850093003279 | 01 | 90030.01 | InSure® ONE™ Combo Pack - contains 25 Collection Kits and 1 Developer Kit | InSure® ONE™ | ENTERIX INC. |
| 41 | 00850093003231 | 01 | 80025.01 | InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 InSure® ONE™ Developer Kit - contains 25 individually-pouched Test Strips and 1 bottle of Run Buffer (9mL) | InSure® ONE™ | ENTERIX INC. |
| 42 | 00850093003187 | 01 | 90002 | InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test S InSure FIT Sample Kit - NOT FOR SALEContains 2 Patient Collection Kits, 2 Test Strips, and 1 Run Buffer Bottle | InSure FIT | ENTERIX INC. |
| 43 | 00850093003095 | 01 | 14103 | InSure FIT Run Buffer - 1 Liter Bottle | InSure FIT | ENTERIX INC. |
| 44 | 00850093003088 | 01 | InSure FIT Test Strip | InSure FIT | ENTERIX INC. | |
| 45 | 00850093003071 | 01 | 11018 | InSure FIT Test Cards for QC - 50 pack | InSure FIT | ENTERIX INC. |
| 46 | 00850093003064 | 01 | 15022 | InSure FIT Kit | InSure FIT | ENTERIX INC. |
| 47 | 00850093003040 | 01 | InSure FIT Combo Pack | InSure FIT | ENTERIX INC. | |
| 48 | 00850093003019 | 01 | 80025 | InSure FIT Developer Kit | InSure FIT | ENTERIX INC. |
| 49 | 00850011007167 | TNR IFOB36 | TNR IFOB36 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |
| 50 | 00850011007150 | TNR IFOB | TNR IFOB | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |